Beto 50 zk

Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the outer packaging is in a foreign language!
Beto 50 ZK (Metoprololsuccinat – 1 A Pharma 47.5 mg)
47.5 mg, prolonged-release tablets
Metoprololi succinas
Beto 50 ZK and Metoprololsuccinat – 1 A Pharma 47.5 mg are different brand names of the
same medicine.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.
Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See
section 4.
Table of contents of the leaflet:

1. What Beto 50 ZK is and what it is used for
2. Important information before taking Beto 50 ZK
3. How to take Beto 50 ZK
4. Possible side effects
5. How to store Beto 50 ZK
6. Contents of the pack and other information

1. What Beto 50 ZK is and what it is used for

Metoprolol succinate (a selective beta-blocker), the active substance in Beto 50 ZK, blocks
certain beta-adrenergic receptors in the body, mainly located in the heart.
Beto 50 ZK is used for:

• mild to moderate heart failure (ejection fraction less than or equal to 40%), which has been stable for at least 4 weeks. Beto 50 ZK is used as an addition to standard treatment with vasodilators (ACE inhibitors) and diuretics, and, if necessary, cardiac glycosides;
• treatment of high blood pressure;
• treatment of chest pain or heart pain (angina pectoris);
• treatment of heart rhythm disorders, including rapid heart rate;
• prevention after the acute phase of myocardial infarction;
• in cases of unpleasant sensation of irregular and/or strong heartbeat (hyperkinetic heart syndrome);
• prevention of migraine.

In children and adolescents aged 6 to 18 years:

• treatment of high blood pressure (hypertension).

2. Important information before using Beto 50 ZK

When not to use Beto 50 ZK

• if the patient is allergic to metoprolol succinate or to any of the other
  components of this medicine (listed in section 6);
• if the patient is allergic to other beta-blocking agents;
• if the patient has severe asthma or severe wheezing attacks;
• if the patient is in shock;
• if the patient has conduction disorders in the heart (second- or third-degree atrioventricular block, high-grade sinoatrial block) or rhythm disorders (sick sinus syndrome), except in patients with a permanently implanted cardiac pacemaker;
• if the patient has severe circulatory disorders (severe peripheral arterial disease);
• if the patient has untreated and uncontrolled heart failure (a condition usually causing breathlessness and ankle swelling);
• if the patient has a slow heart rate (<50 beats/min at rest before treatment);
• if the patient has very low blood pressure (systolic blood pressure <90 mmHg);
• if the patient has abnormally acidic blood (so-called metabolic acidosis);
• if the patient is taking any of the following medicines:
  • monoamine oxidase inhibitors (MAOIs) – medicines used to treat depression, except MAO-B inhibitors (used in Parkinson’s disease);
  • verapamil and diltiazem (medicines used to lower blood pressure);
  • antiarrhythmic medicines such as disopyramide (medicines used to treat irregular heart rhythm).

When using Beto 50 ZK, intravenous administration of certain antiarrhythmic drugs (calcium channel antagonists such as verapamil and diltiazem or other antiarrhythmic drugs) is not allowed. Inform your doctor that you are taking Beto 50 ZK.
Metoprolol must not be used in patients with chronic heart failure if:

• they have unstable, decompensated heart failure (which may manifest as fluid accumulation in the lungs, poor circulation, or low blood pressure);
• they are receiving or have received chronically or intermittently drugs that increase the force of heart contractions;
• they have a slow heart rate (less than 68 beats/min at rest before treatment);
• systolic blood pressure is persistently below 100 mmHg.

Warnings and precautions
Before starting treatment with Beto 50 ZK, discuss with your doctor or pharmacist if:

• the patient has asthma, bronchitis, or lung function disorders, because treatment with bronchodilators may need to be initiated or, if the patient is already taking asthma medication, the dose of bronchodilator may need to be adjusted;
• the patient has heart function (e.g. slow heart rate) or circulatory disorders (treatment with Beto 50 ZK may worsen these conditions);
• the patient has diabetes or significant fluctuations in blood sugar levels;
• the patient is malnourished;
• the patient has mild conduction disturbances from the atria to the ventricles (first-degree atrioventricular block), as this may lead to worsening, potentially resulting in complete blockage of conduction;
• the patient has thyroid disorders;
• the patient has severe liver disease (see section 3 “How to use Beto 50 ZK”);
• the patient has ever experienced a severe allergic reaction to any allergen. Severe hypersensitivity reactions may be more intense during treatment with drugs such as Beto 50 ZK;
• the patient has a rare form of angina, so-called Prinzmetal’s angina;
• the patient is to undergo surgery requiring general anaesthesia. Inform the anaesthesiologist that you are taking Beto 50 ZK;
• the patient has a catecholamine-secreting tumour of the adrenal medulla (phaeochromocytoma): in such cases, prior and concomitant use of an alpha-adrenergic receptor-blocking drug is required;
• the patient has psoriasis.

If the heart rate slows down or becomes irregular, contact your doctor immediately. The doctor may prescribe a lower dose of metoprolol or gradually discontinue Beto 50 ZK.
In patients with acute myocardial infarction, treatment with metoprolol has been associated with an increased risk of severe drop in blood pressure (cardiogenic shock). Since this particularly affected patients with unstable circulation, metoprolol should only be administered after stabilization of circulation in patients with myocardial infarction.
Do not abruptly stop using Beto 50 ZK (see section 3 “Discontinuing treatment with Beto 50 ZK”).
There is limited experience in treating patients with heart failure who:

• have very severe, varying degrees of (unstable) heart failure (NYHA class IV);
• have experienced chest pain or angina of varying severity within the last four weeks;
• have kidney or liver dysfunction;
• are over 80 or under 40 years of age;
• have heart valve disease affecting heart function;
• have cardiomyopathy causing narrowing of the heart cavity;
• have had or are scheduled for heart surgery, if Beto 50 ZK is to be taken within the next four months.

Children and adolescents
Experience with treatment in children under 6 years of age is limited.
The use of Beto 50 ZK is not recommended in children under 6 years of age.
Doping
The use of metoprolol may lead to positive results in anti-doping tests.
Beto 50 ZK and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Beto 50 ZK interacts with many other medicines.

• Medicines used to treat high blood pressure (including prazosin, clonidine, hydralazine, guanethidine, betanidine, reserpine, alpha-methyldopa, and so-called calcium antagonists such as verapamil, diltiazem or nifedipine). If clonidine and Beto 50 ZK are used together and clonidine is suddenly discontinued, blood pressure may rise abruptly and severely. Clonidine must not be stopped before Beto 50 ZK is discontinued several days earlier. Clonidine should be tapered gradually (consult your doctor). Beto 50 ZK must not be started until several days after stopping clonidine.

• Other beta-blocking agents (including those contained in eye drops).

• Medicines affecting peripheral blood circulation (in fingers and toes), such as ergot alkaloids (used to treat migraine).

• Medicines used to treat depression.

• Medicines used to treat other psychiatric disorders.

• Antiretroviral medicines used to treat AIDS and certain other diseases.

• Antihistamines (including over-the-counter medicines used to treat hay fever and other allergies, colds and other conditions).

• Medicines used to prevent malaria.

• Medicines used to treat fungal infections.

• Medicines affecting liver enzyme activity, such as rifampicin used to treat tuberculosis.

• Medicines used to treat heart disorders (including angina), such as amiodarone, digoxin, nitrates and antiarrhythmic drugs.

• Other medicines that reduce heart rate: concomitant use of fingolimod (a medicine used in adults, children and adolescents to treat relapsing-remitting multiple sclerosis) with beta-blockers may enhance the heart rate-lowering effect during the first days of fingolimod treatment.

• Other medicines that lower blood pressure: concomitant use of aldesleukin (a synthetic protein used to treat metastatic kidney cancer) with beta-blockers may enhance the blood pressure-lowering effect.

• Insulin and other antidiabetic medicines. Their blood sugar-lowering effect is enhanced by Beto 50 ZK. Warning symptoms of low blood sugar, especially rapid heartbeat and tremor, may be masked or diminished. Therefore, blood sugar levels should be monitored regularly.

• Non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.

• Local anaesthetics containing lidocaine.

• The medicine called dipyridamole, used to prevent blood clots.

Beto 50 ZK with food, drink and alcohol
Beto 50 ZK and alcohol may mutually enhance their sedative effects. Blood alcohol levels may reach higher values and decrease more slowly.
During treatment with Beto 50 ZK, alcohol consumption should be avoided.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Beto 50 ZK may be used during pregnancy only if clearly indicated and after careful assessment by the doctor of the benefit-risk ratio. There is evidence that metoprolol reduces blood flow in the placenta, which may lead to impaired fetal development.
Treatment with Beto 50 ZK should be discontinued 48 to 72 hours before the expected delivery date. If this is not possible, the newborn should be closely monitored by the doctor for 48 to 72 hours after birth.
Breastfeeding
Beto 50 ZK passes into breast milk.
Metoprolol succinate should not be taken during breastfeeding unless absolutely necessary.
Although adverse effects are unlikely when recommended doses are used, breastfed infants should be carefully monitored for possible drug-related effects (e.g. the doctor will monitor heart function).
Driving and operating machinery
Treatment with this medicine requires regular medical supervision. During treatment with Beto 50 ZK, dizziness or fatigue may occur. These symptoms may affect reaction speed to an extent that may impair the ability to drive, operate machinery or work under potentially hazardous conditions. These symptoms may be particularly pronounced when alcohol is consumed concurrently or when switching from one medicine to another.
Beto 50 ZK contains glucose, lactose and sucrose (sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Beto 50 ZK.

3. How to use Beto 50 ZK

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor or pharmacist.
The following products are available on the market: Beto 25 ZK (23.75 mg), Beto 50 ZK (47.5 mg), Beto 100 ZK (95
mg), Beto 150 ZK (142.5 mg), Beto 200 ZK (190 mg).
Your doctor will inform you how many tablets to take and when. The prescribed dose depends on the type
of disease and its severity.
If your doctor has not advised otherwise, the usual dosing is as follows:

High blood pressure (hypertension)

• Patients with mild to moderate hypertension should take 47.5 mg of metoprolol succinate once daily.
• If necessary, the doctor may increase the dose to 95–190 mg of metoprolol succinate once daily, or add another antihypertensive medicine.

Chest pain (angina pectoris)

• 47.5–190 mg of metoprolol succinate once daily.
• If necessary, the doctor may add another medicine used in the treatment of ischemic heart disease.
• If chest pain or heart pain occurs at night, tablets may be taken in the evening.

Heart rhythm disorders, including rapid heartbeat (arrhythmias)

• 47.5–190 mg of metoprolol succinate once daily.

Treatment after myocardial infarction

• 95–190 mg of metoprolol succinate once daily.

Unpleasant sensation of irregular and/or forceful heartbeat (palpitations)

• 47.5 or 95 mg of metoprolol succinate once daily.
• If necessary, the doctor may increase the dose to 190 mg of metoprolol succinate once daily.

Prevention of migraine

• 95–190 mg of metoprolol succinate once daily.

Heart muscle weakness (heart failure)
Before initiating treatment for heart muscle weakness, the patient's condition must be stabilized with
medicines commonly used in heart failure therapy. The dose of Beto 50 ZK should then be individually adjusted.

• The recommended initial dose during the first week for patients with heart muscle weakness (classified as NYHA class III–IV heart failure) is 11.88 mg of metoprolol succinate once daily. The doctor may increase the dose during the second week to 23.75 mg of metoprolol succinate once daily. The recommended initial dose during the first 2 weeks for patients with heart muscle weakness (classified as NYHA class II heart failure) is 23.75 mg of metoprolol succinate once daily.
• The doctor will then double the dose. The dose may be doubled every two weeks until reaching 190 mg of metoprolol succinate once daily or the highest dose tolerated by the patient.
• The recommended dose for long-term maintenance therapy is 190 mg of metoprolol succinate once daily, or the highest dose tolerated by the patient.

Use in children and adolescents
High blood pressure:
In children aged 6 years and older, the dose depends on body weight. The doctor will determine the appropriate dose for the patient.
The usual initial dose of metoprolol succinate is 0.48 mg/kg body weight once daily, but not exceeding 47.5 mg. The dose should be adjusted to the nearest available tablet strength. The doctor may increase the dose up to 1.9 mg/kg body weight, depending on the blood pressure response. Doses exceeding 190 mg daily have not been studied in children and adolescents.
Beto 50 ZK is not recommended for use in children under 6 years of age.
The duration of treatment is determined by the doctor.
If you feel that the effect of Beto 50 ZK is too strong or too weak, consult your doctor or pharmacist.

Elderly patients
Studies have not been conducted in patients over 80 years of age, therefore the doctor will increase the dose cautiously in such patients.

Beto 50 ZK is intended for oral administration.
Tablets should be taken once daily, regardless of meals. Tablets may be divided into equal doses. They may be swallowed whole or divided, but should not be chewed or crushed. Tablets should be taken with water (at least half a glass).

Taking more Beto 50 ZK than recommended
Seek immediate medical advice or go to the nearest hospital emergency department. Based on the severity of poisoning symptoms, the doctor will decide on appropriate management.
Show the medicine packaging to the doctor so that it is clear which medicine has been taken and what action should be taken.

Symptoms of overdose
Symptoms that may occur following overdose of Beto 50 ZK include:
dangerously low blood pressure, severe heart function disturbances, breathing difficulties, bronchospasm, shock, loss of consciousness (or even coma), seizures, nausea, vomiting, cyanosis (blue or purple skin discoloration), and death.
The first symptoms of overdose may appear within 20 minutes to 2 hours after taking Beto 50 ZK, and effects of significant overdose may persist for several days.

Treatment of overdose
The patient should be treated in a hospital, in an intensive care unit. Even patients who appear to be in good condition after a minor metoprolol overdose should be closely observed by a doctor for at least 4 hours for signs of poisoning.

Missing a dose of Beto 50 ZK
Do not take a double dose to make up for a missed dose. Continue treatment as directed by your doctor.

Stopping Beto 50 ZK treatment
Before stopping or prematurely discontinuing treatment with Beto 50 ZK, consult your doctor.
Beto 50 ZK should not be stopped abruptly, but the dose should be gradually reduced. Sudden discontinuation of beta-blockers may worsen heart failure symptoms and increase the risk of myocardial infarction and sudden cardiac death.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Very common (may affect more than 1 in 10 people):

• feeling of fatigue.

Common (may affect up to 1 in 10 people):

• dizziness, headache
• slow heart rate (bradycardia)
• palpitations
• significant lowering of blood pressure, especially when changing position from lying down to standing, very rarely with loss of consciousness
• coldness of hands and feet
• breathing difficulties during exertion in predisposed patients (e.g. patients with asthma)
• nausea, abdominal pain, diarrhoea, constipation.

Uncommon (may affect up to 1 in 100 people):

• weight gain
• depression, drowsiness, sleep disturbances, nightmares, difficulty concentrating
• abnormal sensations of tingling, pricking or numbness of the skin (paraesthesia)
• transient worsening of symptoms of heart muscle weakness (with swelling of ankles and feet), first-degree atrioventricular conduction block (first-degree AV block), chest pain (angina), poor cardiac pump function (cardiogenic shock) in patients with myocardial infarction (acute myocardial infarction)
• bronchospasm (bronchoconstriction)
• skin rash (psoriasiform and dystrophic skin changes), increased sweating
• muscle cramps.

Rare (may affect up to 1 in 1,000 people):

• worsening of diabetes without characteristic symptoms (latent diabetes)
• nervousness, blurred vision, dryness or irritation of the eyes (noticeable during contact lens use), conjunctivitis
• heart rhythm disorders (arrhythmia), conduction disturbances
• nasal congestion
• dry mouth
• abnormal liver function test results
• hair loss
• impotence and libido disorders, Peyronie's disease (plastic induration of the penis).

Very rare (may affect up to 1 in 10,000 people):

• reduced number of blood platelets (thrombocytopenia), reduced number of white blood cells (leukopenia)
• forgetfulness or memory disturbances, confusion, hallucinations, personality changes (e.g. mood swings)
• ringing in the ears (tinnitus), hearing impairment
• tissue necrosis (necrosis) in patients with severe peripheral circulatory disorders prior to treatment
• taste disturbances
• hepatitis
• photosensitivity with skin rash after exposure to light, exacerbation of psoriasis symptoms, development of psoriasis
• joint pain, muscle weakness.

Frequency not known (frequency cannot be estimated from available data):

• abnormal blood levels of certain types of lipids, such as cholesterol or triglycerides
• worsening of symptoms in patients with intermittent claudication or with blood vessel spasms in fingers and toes (Raynaud's phenomenon).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Beto 50 ZK

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number / expiry date – see imprint
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the packaging and other information

What Beto 50 ZK contains
Active substance:
Metoprolol succinate.
Each prolonged-release tablet contains 47.5 mg of metoprolol succinate, equivalent to
50 mg of metoprolol tartrate.
Other ingredients:
Sucrose, granules (sucrose, corn starch, liquid glucose), polyacrylate dispersion 30%, talc,
magnesium stearate, microcrystalline cellulose, crospovidone, colloidal anhydrous silica.
Coating: lactose monohydrate, hypromellose, titanium dioxide (E171), macrogol 4000.

What Beto 50 ZK looks like and contents of the pack
White, elongated tablets with a score line on both sides.
Prolonged-release tablets are packed in blisters made of PP/Aluminium foil or PVC/Aclar/Aluminium foil,
contained in a cardboard box.
Pack sizes: 30 or 60 prolonged-release tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Germany, the country of export:
1 A Pharma GmbH
Industriestraße 18
83607 Holzkirchen
Germany

Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

German marketing authorisation number (country of export): 61499.01.00
Parallel import authorisation number: 63/26